Agnes Shanley is senior editor of Pharmaceutical Technology.

Agnes Shanley

	The industry has weathered its share of “black swan” events. Who, for instance, could have predicted the shortages of the workhorse solvent, acetonitrile, that brought so many pharmaceutical labs to their knees back in 2009? More than one event led to that shortage-a hurricane in Texas and a storm in Ohio that, simultaneously, took out 90% of the US supply-explains Charlotte Hicks, a supply-chain expert who established the web site, supplychainriskmitigation.com.

	There are some basic ground rules for monitoring risks, though. For one thing, small-volume users of any material should always anticipate larger users’ needs. For instance, the oil and gas industries are major users of hydrochloric acid, so increased production will mean less material available for smaller companies, says Hicks.
	In the US, she explains, conditions and supplies of natural excipients may be radically different during El Niño years. In fact, problems can be triggered by events as basic as a change in seasons. For instance, in colder parts of the country, starting in November, some supplies of water for injection (WFI) must be transported in heated trucks over the Rocky Mountains, a factor that adds cost and may affect availability.

	Even the smallest company can begin to take stock of issues by using tools as basic as Microsoft Excel spreadsheets, Google maps, and Google alerts, says Hicks. “Take all suppliers and addresses and then drop that into Google maps,” she says, “to simplify the analysis and impacts of events such as hurricanes, earthquakes and geopolitical unrest.” Google Alerts can then help monitor news for all suppliers, using company names, locations, chemical names, and disasters as search terms. Technologies have been developed to help  manufacturers discern, and act on, events that could trigger potential supply chain risks. RAAD360, for example, offers a program that allows companies with enterprise resource planning (ERP) systems to mine the supplier data that is already within these systems to discover specific patterns that might lead to shortages.  

	Other companies such as Elementum, Resilinc, and Risk Methods offer apps and software-as-a-service solutions that mine supplier risk data, examine customer data, and pinpoint potential problems. These companies put that data out on the cloud.

	When referring to this article, please cite it as A. Shanley, "Tracking Potential Threats" sidebar to "Managing Risk in Raw Material Sourcing,” 

Articles

The pharmaceutical industry has weathered its share of “black swan” events.

Tracking Potential Threats

Choosing excipients and suppliers for pharmaceutical formulations requires a clear understanding of product requirements; material properties; product, process, and material variability; and vendor practices. The goal is a safe, robust formulation that will meet bioequivalence and stability requirements, but also enable validatable manufacturing, explained Chris Moreton, consultant with FinnBrit Consulting, during a September 2016 webcast (1).

	But there are many factors at play that seem random and cannot be easily predicted-not only natural disasters, but what the statistician Nassim Nicholas Taleb has called “black swan” events (2), from sudden fires and plant accidents to geopolitical problems and the constant threat of economically-motivated product adulteration.

	The burden is on finished-drug manufacturers to understand and manage all of these variables. A ripple effect is also being seen among proactive pharmaceutical ingredient suppliers, which are requiring more transparency from their suppliers. In a business environment in which final drug product manufacturers with even the most advanced programs can typically only see two levels deep into their supply chains (3), this represents progress. A number of technologies, and even effective do-it-yourself approaches, are available to help companies map and monitor supply chain risks (

	In light of the heparin, melamine, and other supply-chain disasters of recent years, there is more pressure than ever for pharmaceutical manufacturers to develop better supplier qualification practices, said Priscilla Zawislak, chair of the International Pharmaceutical Excipients Council (IPEC), on the webcast. Risk management is the key to avoiding batch failures, as well as adverse effects in patients, she explained. IPEC has developed standardized templates and materials to help simplify supplier evaluation and auditing, as well as the development of quality agreements (

), and to ensure consistency. Having additional “just-in-case” suppliers on hand for key ingredients is also important to reduce risk, she said.

	Pharmaceutical manufacturers are demanding not only cGMP compliance, documentation support, and close management of critical changes, but increased information transparency from their suppliers, says Devashish Ohri, executive vice-president with the API and excipient supplier, Avantor Performance Materials. In turn, some ingredients suppliers are requiring more provenance information from their suppliers. “Plant-of-origin information and transparency regarding the source of raw materials is essential for traceability,” he says.

	Avantor has globalized and standardized quality systems at its facilities to help ensure consistency and continuity, establishing certified cGMP capacities in its facilities, including its site in Panoli, India, which, Ohri says, is ramping up production of J.T.Baker high-purity low endotoxin (HPLE) sugars, as well as multi-compendial cGMP excipients, in 2016.

	“Our efforts are focused on compliance with the International Council for Harmonization’s (ICH) Q7 (for APIs) and IPEC (for bulk pharmaceutical excipients) guidelines to continuously improve our systems and ensure quality, safety, and functionality of pharmaceutical excipients,” says Ohri.

	Guiding supplier selection, he says, are goals of consistent quality, uninterrupted supply, and availability of necessary documentation to support transparency efforts. Facility audits and product quality monitoring are an important part of supplier quality management, he says. Avantor has installed MasterControl quality management system (QMS) software across its cGMP manufacturing sites to manage documents, quality training, corrective actions and preventive actions, and other operations, says Ohri, who adds that ICH Q7 and IPEC guidelines helped shape the company’s change-management process. “It is important to ensure that any changes that might affect the products that customers buy or make, including changes to manufacturing processes, raw materials, product specifications, product transfers, and analytical testing, be managed and approved in a structured, cross-functional way,” he says.

	To identify and assess risk, the company uses a documented risk-assessment process, facility audits, and a toolkit that includes such methods as failure modes and effect analysis, fishbone diagrams, and fault tree analysis, as well as hazards analysis and critical control point techniques, says Ohri. The company has established sites in the United States, Europe, and India, based on customer demand for local materials. For Avantor’s offshore suppliers, he adds, the use of (local) advisors helps ensure compliance and consistent performance.

	Big Pharma companies and large generic-drug manufacturers have also been strengthening their supplier oversight and supply-chain risk monitoring practices. Several years ago, Pfizer made supply-chain security practices part of its quality manual, implementing an enterprise-wise scorecard for each supplier (4). J&J has set up supply chain risk monitoring centers of excellence and is using a filter of “reliability, risk, and readiness” to evaluate suppliers (3). Teva, meanwhile, has developed a systematic risk-based approach for reviewing suppliers, including their efforts in serialization (5).

Best Practices for Effective Excipient Sourcing and Testing

 webcast, September 2016 (archived until September 20, 2017). 
	2. N. Taleb, The Black Swan: The Impact of Highly Improbable Events, Second Edition (Penguin, London, 2012). 
	3. A. Shanley, “

,” PharmTech.com, April 2, 2016.
	4. J. Skutnik-Wilkinson, “

Management of the Supply Chain: Excipients and APIs

,” a presentation made at the Pharmaceutical Quality Systems (ICH Q-10) Conference, October 4-6, 2011, Arlington, Va., FDA.gov.
	5. A. Shanley, “

Serialization: Getting Past the Quick Fix

	When referring to this article, please cite it as A. Shanley, "Managing Risk in Raw Material Sourcing,” 

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

Managing Risk in Raw Material Sourcing

	In 2009, the International Pharmaceutical Excipients Council (IPEC) introduced an Excipient Information Package (1) that includes a product requirement datasheet, site quality overview, and site and supply chain security overview, providing a standard format and consistency across suppliers and product lines.“It can save the time usually wasted tracking down individual supplier questionnaires,” said IPEC Chair Priscilla Zawislak in a September 20, 2016 webcast hosted by Pharmaceutical Technology (2). IPEC also offers quality agreement templates (3) for  pharmaceutical manufacturers and excipient suppliers and distributors, and will add templates for manufacturer agreements with both distributors and original manufacturers. 

	When referring to this article, please cite it as A. Shanley, "Standardized Templates Can Help Make the Job Easier,” sidebar to "Managing Risk in Raw Material Sourcing," 

In 2009, the International Pharmaceutical Excipients Council introduced an Excipient Information Package that includes a product requirement datasheet, site quality overview, and site and supply chain security overview.

Standardized Templates Can Help Make the Job Easier

) by Ariad, Valeant, Mylan, and Turing Pharma, which raised the price for a niche anti-infective by 5000% in 2015, have intensified public criticism of the pharmaceutical industry. In many of these cases, these increases affected older drugs that cost only a few dollars per dose to make and were positioned as “passalong costs” to offset business losses or make up for the cost of the new drug pipeline, or, as Turing’s official response said, “to balance patient access to existing drugs with investment in research and value generation for our shareholders” (1).  In each case, company stock prices fell along with public opinion (2).

	While Mylan’s CEO blamed changes in the US healthcare insurance landscape for making the price change visible (3), pharmaceutical manufacturers were quick to distance themselves from Turing’s over-the-top maneuver. However, drug companies often note the cost and time required to develop a new drug, which the Tufts Center for the Study of Drug Development pegs at $2.6 billion and 10 years in its latest study (4), and the high rate of failure for new drug candidates, especially during Phase III, when manufacturing comes into play. 

	Other challenges they point out are restrictions set by insurance companies and other payers, and limits to patient access established by such authorities as the National Institute for Health and Care Excellence (NICE) in the United Kingdom. “Overall, companies are under pressure to keep costs down, and organizations like NICE use increasingly sophisticated models to assess net clinical benefit versus cost,” says Gawayne Mahboubian-Jones, a consultant based in Switzerland. “Pressure on public purse-strings enables such organizations to play ‘hardball’ with drug approvals.”

	In September 2016, the Biotechnology Innovation Organization set up a web page to emphasize the insurance industry’s role in high healthcare costs and debunk the idea that industry price increases were out of line with costs (5). But discussions about drug prices also raise other questions, among them, whether, and how, pharmaceutical R&D and manufacturing might become more efficient. Pharmaceutical companies have made changes in the way their research and development programs are set up, moving to collaborative and hub models, and new drug approvals have been trending up.

	Many companies have implemented operational excellence and Lean Six Sigma programs, not only in manufacturing but in R&D. “This has had varying results, with the biggest challenge being the balance between the risk and benefit of certain redundant processes,” says Henry Levy, CSO at Veeva Systems, Inc. “This risk becomes complex when considering the needed interpretation of regulation, because guidances [from global regulatory bodies] always allow for individual company decisions.”

	However, the industry still wastes billions of dollars each year on inefficient practices using outdated technology. Today, there is little current information available on pharmaceutical manufacturing costs.  In the late 1990s, researchers at the Massachusetts Institute of Technology’s Program on the Pharmaceutical Industry  (POPI) estimated that manufacturing cost the world’s eight largest pharmaceutical companies 27% of their revenue each year (6).

	In 2006, one study found that the industry wasted $50 billion or more each year, due to regulatory issues and redundant or time-consuming manufacturing and quality-control practices (7).  In 2007, professors of finance at a number of universities estimated that improvements to pharmaceutical manufacturing alone (i.e. a 30% reduction in manufacturing costs)could result in $1 trillion in savings, if manufacturers reduced prices, and $12.3 billion if they did not reduce prices, allowing some of that money to be used to fund R&D or social programs (8).

	Manufacturing costs, for the typical pharma company, are only approximately 10% of the outlays made in R&D, says Mahboubian-Jones. R&D remains the most costly part of the pharmaceutical value chain, largely because companies still take what Mahboubian-Jones called a “scattershot,” or one-off approach, to research.  “Pharma companies have only poor control of R&D costs, not because control mechanisms do not exist, but because the mindset at many companies is still to chase the next blockbuster, where R&D cost remains small compared to profit,” he says. “Unfortunately the true blockbusters of the 1990s and 2000s have all but disappeared. Most medicines are more specific, better targeted to a smaller market, and purchasing groups are now much more restrictive on what they are prepared to pay.”  As he notes, companies often respond to this situation by cutting manufacturing costs rather than development costs, typically, because they have already gone through their R&D budgets.

	A major challenge is improving processes for clinical trials, which account for most of the cost of R&D (9). Data from the Tufts Center for Drug Development, which are usually used to explain industry costs, offer insights. Critics and patient groups (10, 11) have asked for greater transparency about the methods used to estimate the totals.

	In his blog, James Love of Knowledge Economy International has suggested that Tufts’ estimates be supplemented by other data, such as numbers generated by the Pharmaceutical Research and Manufacturers of America and Battelle, which showed the average cost per patient in a clinical trial to reach $36,000 ($59,500 for cancer drugs) (12).

	Whether or not one agrees with them, the Tufts Center numbers reflect an extremely challenging environment, showing phase I clinical costs to be $25.3 million ($213.9 million when adjusted for risk), with the cost of failures during this phase reaching $188.6 million. Phase II costs are estimated at $58.6 million ($295 million when adjusted for risk), with cost of failure, $236.4 million, and phase III costs at $255.4 ($456.5 million), with cost of failures, $201.1 million.

	These numbers raise some important questions. “Why are companies discovering, at Phase III, that drugs don’t work?” asks Girish Malhotra, consultant in manufacturing process development and optimization and principal of EPCOT International in Cleveland. “In API process development and formulation, it is essential to understand and have a command of the process before it is commercialized,” Malhotra says. “Such command would allow companies to produce quality from the get go rather than testing it in, as is currently the case,” he says.

	“There is a need for better, more mechanistic models for predicting a drug’s behavior,” says Mahboubian-Jones. “Until we develop and improve that ability to predict behavior, we will continue to have to use the ‘try it and see’ approach,” he says.  One potential solution, he says, would be restricting the extent to which companies can write off the costs of failures against the profits of successful drug launches.  “This would have to be done carefully or it could run the risk of shutting down the drug- development process,” he says.

	“Another factor influencing clinical trials and drug development is payer pressure, which demands that trials deliver clear, unequivocal benefit, which is not only increasing costs but is changing the nature of clinical trials,” says Mahboubian-Jones. Data management is also a major problem, and Ken Getz, associate professor and director at Tufts University School of Medicine, has attributed drug development delays and inefficiencies to “clinical trial protocol complexity, operating fragmentation, and the use of disparate IT solutions”(13).

	The greatest obstacle to improving pharmaceutical manufacturing, experts agree, is failing to understand the cost of poor quality (COPQ) on overall business. This failure, says Malhotra, has had a crippling effect on the industry’s ability to innovate.

	All too often, COPQ is seen as a part of doing business in a regulated environment, a risk that you take in order to get the best benefit, says Mahboubian-Jones. “This ‘ghettoization’ of quality continues to be one of the biggest inhibitors of real progress in the pharma industry,” he says.

	“Sometimes the cost of poor quality is not even measured, or, maybe even worse, is not measured properly,” says Ben Locwin, president of Healthcare Science Advisors. He has seen the cost of poor quality reach 42% of overall production costs at some companies. “It’s typically quoted as 10-30% of sales, but in reality, it’s often sustained at the upper end of this range,” he says.

	For some generic-drug manufacturers, there has been too rigid a focus on cost reduction, which can lead to noncompliance, says Mahboubian-Jones, who notes that initiatives such as process analytical technology were never fully embraced in this sector.

	Nevertheless, there are signs that progress is being made.  FDA has funded a study measuring product quality in an operational excellence environment, which is being conducted by Prabir Basu in the United States and Thomas Friedli at the University of St. Gallen in Switzerland (14) that will analyze trends.

	Several companies have made process, documentation and training improvements, and have also improved regulatory compliance, resulting in fewer deviations and reducing the cost of goods sold, notes Locwin. “These improvements lead businesses to a state where they can better deliver what they claim with fewer nonconformities and employee errors,” he says.

	Regulatory issues may be impeding the industry’s desire to invest in new and more efficient IT platforms and process technologies. Filing for changes to existing processes, even changes that would reduce risk and improve efficiencies, has become an ordeal for many global pharmaceutical companies today.

	“Consider the product lifecycle,” says Maik Jornitz, who led the Parenteral Drug Association’s Aging Facilities task force. “When we cannot make a process change, and it takes four, five, or six years before the change can be made globally, there will be very little motivation for improvement,” he says.

	Despite the challenges, there are signs that improvement is on the way, with research approaches such as risk-based monitoring (15). “When done well, this approach can improve predictive capabilities and success rates for clinical trials,” says Locwin.

	1. A. Pollack and M. Goldstein, “Martin Skreli All But Gloated Over Higher Prices, Memos Show,” NewYorkTimes.com, Feb. 2, 2016, 
	2. D. Bloomfield, “Bernie Sanders Follows ‘Greed” Tweet on Ariad With Letter,” Bloomberg.com, October 20, 2016. 
	3. B. Brian, “Mylan CEO Blames Obama Care for Epipen Price Increase,” BusinessInsider.com, August 3, 2016. 
	4. J.A. De Masi et al, 

, 47 (2016).
	5. Unsurance: Facts About Insurance, BIO.org, www.bio.org/insurance-facts
	6. C. Cooney, “Benchmarking Pharmaceutical Manufacturing Performance,” MIT Program in the Pharmaceutical Industry (POPI), Working Paper, Cambridge, Mass, 1996: pp 33-96.
	7. J. Macher and J. Nickerson, “

The Pharmaceutical Manufacturing Project.

, 2007, Vol 41, pp. 229-239.
	9. K. Getz, 

Letter to Anthony De Masi and the Tufts Center for Drug Development

, csdd.tufts.edu, Feb. 3, 2015.
	11. D. Light and R. 

, April, 2011, posted Feb. 7, 2016, on Pharmamyths.net.
	12. J. Love, “

The 2016 Tufts Estimates of the Risk-Adjusted Out-of-Pocket Costs to Develop a New Drug

,” keionline.org, April 12, 2016.
	13. “Veeva Announced EDC and eSource to Transform Clinical Data Management” Press Release, October 13, 2016.
	14. 

, Pharmtech.com, Oct. 19, 2016.
	15. Zurdo et al, Developability of Biotherapeutics,Zurdo et al., Chapter 10, Developability Assessment Workflows to De-Risk Biopharmaceutical Development, (CRC Press,) 2015

	When referring to this article, please cite it as A. Shanley, "What Price Healing?” 

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

What Price Healing?

	Recent astronomical price increases have driven accusations that some pharma companies are price-gouging, and galvanized public opinion against an industry whose popularity has been slipping for the past 10 years. Beyond any ethical or business questions, have the actions of a few senior managers at some companies prevented an honest dialogue with the public, and a clearer understanding of the cost issues affecting most drug developers?

 United States Senator Bernie Sanders and Representative Elijah Cummings write to Ariad Pharma’s CEO asking him to explain the “repeated and staggering price increases” that raised the price of its leukemia treatment Iclusig by 40% to $200,000/yr, in less than a year (1).

 US Representative Dan Kildee of Flint, Michigan, which has been declared a state of national emergency since its municipal water supply was found to be contaminated with lead in June 2016, asks Congress to investigate Valeant Pharma for raising the price of a lead poisoning treatment from $900 to $2700 per month (2). In February and April 2016, senior executives from the company testified before the US House of Representatives Committee on Oversight and Government Reform, and before a senate committee, after increasing prices for two heart treatments.

 Hillary Clinton accuses Mylan NV of “price gouging” when it increased the price of its EpiPen treatment, which had gone from $57 per single injector when Mylan bought the technology from Merck in 2007, to over $600 per pack of two (3). The company’s CEO testifies to Congress in September, and Mylan settles an overpricing case with the Department of Justice for $465 million (4). By October 2016, at least one consumer class action lawsuit has been filed against the company (5).

 Turing Pharma writes the precedent-setting script for these scenarios when it raises the price for Daraprim, a 60-year-old drug used to treat toxiplasmosis that it had recently acquired, increasing its price from $13.50 to $750 per tablet (6). Its former CEO testified before the US House of Representatives in February 2016. Various media outlets report him referring to Mylan’s senior management as “vultures” (3) after the EpiPen price increase was announced, and then suggesting that Mylan should have increased prices even more (6).

Bernie Sanders Follows ‘Greed’ Tweet on Ariad with Letter

,” Bloomberg.com, October 20, 2016.
	2. M. McIntire, “

Flint Lawmaker Urges Probe into Lead Poisoning Drug Price Hike

,” October 20, 2016, MorningConsult.com.
	3. E. Willingham, “

Why did Mylan Hike Epipen Prices by 400%?  Because They Could

,” NewYorkTimes.com, October 19, 2016.
	5. M. Mitchell, “

Mylan Faces Federal Class Action Over EpiPen Pricing

As Turing Took Steps to Acquire a Life-Saving Drug, CEO Shrekli Saw Dollar Signs

	When referring to this article, please cite it as A. Shanley, "Stranger than Fiction" sidebar to "What Price Healing?” 

Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.

Stranger than Fiction

	The distributed ledger technology that underpins digital currencies such as Bitcoin, offers a number of benefits for data transfer, including authenticated transactions that cannot be tampered with, and that can be distributed to different business partners.

	One of its greatest strengths if the fact that it allows data to be shared within trusted networks, without requiring the development of customized interfaces.

	A number of industries are looking into ways that advanced digital ledger technology (ADLT) might be used, for instance, to back up electronic currencies, or to determine provenance (ownership) of diamonds and fine art.  It is also being evaluated by the music industry as a way to handle copyright recording and royalty payments, by Australia as a way to secure voting data, and , in the UK, as a way to ensure data security around nuclear facilities.

	"Virtual ledger technology provides an opportunity when an organization needs to create a bridge between existing systems for internal business units, or with external service providers that do not communicate with each other," explains Darryl Glover, chief clinical officer and a co-founder of isolve, a company that is focusing on blockchain applications in pharma and healthcare.

	 “The advantage, especially in regulated industries, is that an ADLT bridge creates decentralized, immutable, and auditable records that regulators can examine at any time, creating transparency and trust between organizations, since  they are all working from a single source of truth,” says Glover.

	A blockchain does more than a database, because it allows users to store data in a linear container space that can be seen by others.  The container is digitally signed, allowing anyone to verify its authenticity, although only designated users can unlock what is inside the container (1).

	It seems like a natural for e-pedigree and drug traceability requirements, which require the connection of completely unrelated databases (e.g., drug manufacturers data with drug wholesaler or point-of-use data), as required by the drug supply chain security act (DSCSA). “It would allow users to track everything from when the first ingredient arrived at a manufacturing plant to when the first patient customer took the drug, says Glover, “so it can potentially track every point in the supply chain, from beginning to end.”

	The financial services industry has been evaluating the technology for some time. Accenture, Goldman Sachs and a number of management consulting groups are studying it closely.

	iSolve’s global asset exchange platform leverages blockchain to connect companies, investors, tech transfer offices, and service providers and record agreements, contracts, facilitate royalty payments, and handle other transactions.

	Established in 2014, the company began to focus exclusively on pharma in 2015, and a pilot, the BlockRx Project, was launched in 2016 to evaluate potential applications. 

	But track and trace would not be the only potential application in pharma, says Glover. It could also be used in:

		Clinical trials, to verify patient identity and transfer data from a contract research organization (CRO) to a pharmaceutical manufacturer to a regulatory agency

		New drug application submissions to regulators in countries that now accept only paper submissions. 

		Tracking the origins of potential compounds

		Connecting equipment data with the QC lab

	Currently, iSolve is working with the nonprofit Center for Supply Chain Studies, in a project that will use simulation to track a theoretical supply chain. The goal will be to see how blockchain technology might be used to help pharmaceutical companies comply with the Drug Chain Security Act. The regulation requires all trading partners in the supply chain to be able to share transaction information and, when requested, produce all related data.

	Blockchain would offer a number of advantages for recording and transferring data, although Bob Celeste, head of the Center for Supply Chain Studies, notes that there are questions of how much it would cost to use for each application, who would pay, etc. 

	On the IT side, the technology could streamline and decentralize data management, says Glover. “IT does not require any new IT 

, and it does not replace existing IT platforms, but, rather, helps to bridge them using a ‘network in a network,’ “ he explains.

	“For example, a company like McKesson would not have to maintain 500 different blockchains, only one blockchain containing information for all of its suppliers,” says Glover. In addition, blockchain technology has the virtue of being unattackable, he says.  “Bitcoin has been around for 10 years and during that time it has never been hacked.” It also records a transaction permanently.  “Once a transaction is placed in this ledger, it is there forever,” says Glover.

	Blockchain works with large amounts of data, so it may require additional servers, but that data would be decentralized, says Glover, so, for example, Pfizer could keep all its blockchain data in one place instead of having to store it in different dedicated computers.  “You can also have private blockchains, in which only computers and groups that can use the data will actually have access to it,” Glover says.

	The project with the Center and iSolve is expected to result in simulated reference models, a white paper and additional educational materials. As Glover notes, there is industry interest, but pharma's familiarity with the technology is still at a very early stage. 

	The Center and iSolve cosponsored a webinar on September 30, 2016, that attracted over 70 companies, representing all the key stakeholders in the pharma supply chain, including contract manufacturing organizations (CMOs), says Celeste.  Presentations from that webinar may be found on the Center’s 

	A core group from those attendees will become an advisory group and task force to provide data and a reality check for the simulation.  Initial findings are expected in November, and final results of this phase of the study are expected to be published in December, 2016.

	A conference on blockchain technology in pharma, called the Pharma Blockchain Bootcamp, will be held on November 16, 2016 in Edison, NJ.  For more information, visit www.RXBlockchainBootcamp.com.

Pharmaceutical manufacturers and business partners are studying how Advanced Digital Ledger Technology might solve supply chain and other data transfer problems.